This invention relates to novel spiro[1,2-benzisothiazole-3(2H),5'-oxazolidine]-2',4'-dione 1,1-dioxides, to the processes for their preparation, to methods for using the compounds, and to pharmaceutical formulations thereof. The compounds have pharmaceutical properties which render them beneficial for the treatment of diabetes mellitus and associated diabetic complications.
Non-insulin dependent diabetes mellitus (Type II diabetes) is usually treated by a regiment including diet, exercise, oral agents such as sulfonylureas and, in more severe cases, insulin. Many of these hypoglycemic agents exhibit severe side effects. This, along with their generally limited efficacy, has created a need for new, novel and more potent antidiabetic agents which do not possess these drawbacks.
Ciglitazone [(+)-5-[4-[(1-methylcyclohexyl)methoxy]benzyl]thiazolidine-2,4-dione] is currently considered one of the most unique and promising drugs for treatment of hyperglycemia and hyperinsulinemia [Fujita et al, Diabetes, 32, 804 (1983)] because it only normalizes these parameters. The compounds of the present invention also possess antihyperglycemic activity and are of novel structure. Accordingly, the present compounds represent an important new approach for the treatment of diabetes mellitus.